Steritec Products Inc., a member of the Getinge Group, manufactures sterilization and cleaning medical device consumables using ink technology. We manufacture and print highly specialized proprietary inks that undergo specific color changes when exposed to different sterilization conditions in hospital and industrial/pharmaceutical sterilizers.
Job Function Summary:
Assists with current processes, and development of new processes in support of R&D, Manufacturing and Product Development. Provides support and guidance on validation activities related to manufacturing/test equipment and processes.
Primary “essential” Duties and Responsibilities:
• Works to improve efficiency and effectiveness of manufacturing and other facility processes.
• Provides Process Design Engineering guidance to R&D, Manufacturing and Product Development.
• Assists with process flow documentation and design including process steps, workflow and material handling techniques.
• Assists with applying statistical analysis techniques.
• Assists with R&D protocols for new product introduction.
• Provides input to new equipment designs with emphasis on concurrent engineering and improved productivity techniques.
• Assists with process documentation generation and maintenance.
• Participates in new equipment qualification and validation.
• Participates in process and test method qualification and validation.
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities:
• Successful project management experience is required.
• Experience in problem solving and troubleshooting using statistical and analytical tools required.
• Excellent communication skills, ability to work in a team environment and ability to lead a project team.
• Demonstrated knowledge and application of Lean concepts preferred.
• Demonstrated creative problem solving in a regulated manufacturing environment.
• Bachelor's Degree in Engineering, or equivalent.
• Minimum three years progressive experience in a medical device environment.
• Experience in analysis of manufacturing processes, development of process improvements and validation of process changes desired.
• Knowledge of statistical techniques and sampling for process validation and process monitoring is desired.
• Basic computer skills including word processing and spreadsheet experience required.
• Strong MS computer skills including MS Office Suite (Word, Excel) are required.
• Working knowledge of Minitab preferred.
• Experience with Agile PLM or other documentation management system desired.
Environmental/Safety/Physical Work Conditions:
• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are mainly performed in an office environment.
• Duties may be required to be performed in a controlled environment following specific gowning procedures.
• May work extended hours during peak business cycles.
• The individual must occasionally lift and/or move up to 15 lbs.
• Ability to utilize computer and telephone equipment and other related office accessories/devices to complete assignments.
• While performing the duties of this job, the employee is frequently required to stand, walk and sit.
• The employee must have use of hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; speak and hear.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Internal and External Contacts/Relationships:
• Internal: Team members (including contractors), all Getinge colleagues including the executive and leadership team, Finance, Purchasing, Quality, R&D, Logistics and Inventory Control teams. Follow up with all levels of management for clarification/approval on reports as needed.
• External: Contractors, consultants, vendors, 3rd party providers, etc.
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